EP3936089A1 - Système de pose d'endoprothèse - Google Patents

Système de pose d'endoprothèse Download PDF

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Publication number
EP3936089A1
EP3936089A1 EP20766590.2A EP20766590A EP3936089A1 EP 3936089 A1 EP3936089 A1 EP 3936089A1 EP 20766590 A EP20766590 A EP 20766590A EP 3936089 A1 EP3936089 A1 EP 3936089A1
Authority
EP
European Patent Office
Prior art keywords
shaft
distal end
stent
proximal end
axis direction
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP20766590.2A
Other languages
German (de)
English (en)
Other versions
EP3936089A4 (fr
Inventor
Yukihiro FUSEYA
Marina TSUZUKU
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Asahi Intecc Co Ltd
Original Assignee
Asahi Intecc Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Asahi Intecc Co Ltd filed Critical Asahi Intecc Co Ltd
Publication of EP3936089A1 publication Critical patent/EP3936089A1/fr
Publication of EP3936089A4 publication Critical patent/EP3936089A4/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/0069—Tip not integral with tube

Definitions

  • the disclosed embodiments relate to a stent delivery system.
  • a stent obtained by weaving a metal wire in a mesh shape is known.
  • a dilator has a tapered distal end portion that increases in diameter toward a proximal end side, and when the tapered part passes through a constricted part or the like, this constricted part or the like is widened (e.g. see Patent Literature 1). Then, the stent in a diameter-decreased state is inserted into the widened constricted part or the like, then this stent is widened outward in a radial direction and placed in the constricted part, so that the constricted part of the blood vessel, the digestive tract, or the like can be stably widened.
  • Patent Literature 1 Japanese Patent Laid-Open No. 2008-11867
  • the preliminarily widened constricted part or the like may be constricted again in a body cavity such as a significantly elastic blood vessel or digestive tract, and smooth operation may be disturbed by necessity of additional preliminary operation, or the like.
  • the disclosed embodiments were made based on the above circumstances, and an object of the disclosed embodiments is to provide a stent delivery system capable of smoothly placing a stent in a body cavity such as a blood vessel and a digestive tract.
  • This disclosure includes some aspects:
  • distal end side means a direction along the long axis direction of the distal end shaft, in which the distal end shaft is located with respect to the inner shaft.
  • proximal end side means a direction along the long axis direction of the distal end shaft, which is a direction opposite to the distal end side.
  • distal end refers to a distal end portion of any member or part
  • proximal end refers to a proximal end portion of any member or part.
  • the “outermost periphery” means a shape formed by an outline of a particular member (spirally-arranged protruding portion, outer shaft, etc.) as viewed from the long axis direction of the distal end shaft.
  • the disclosed embodiments can provide a stent delivery system capable of smoothly placing a stent in a body cavity such as a blood vessel.
  • the stent delivery system includes: a distal end shaft that has an inner cavity and a tapered portion having an outer diameter gradually increasing from a distal end to a proximal end; a spirally-arranged protruding portion that is provided on an outer peripheral face of the tapered portion and has a gap between adjacent sections along a long axis direction of the distal end shaft; an inner shaft that is connected to the proximal end of the distal end shaft, has an inner cavity communicating with the inner cavity of the distal end shaft, and extends toward the proximal end side of the distal end shaft in the long axis direction; a self-expanding stent that covers the inner shaft and is expandable and contractable in a radial direction of the inner shaft; and an outer shaft that covers the inner shaft and is slidable along a long axis direction of the inner shaft: and is characterized in that the outer shaft is slidable between a first position where the stent in a contracted state is covered and a second position on
  • FIG. 1 is a schematic side view of an embodiment of the disclosed embodiments, illustrating a state that the outer shaft is at the first position.
  • FIG. 2 is a schematic front view of FIG. 1 .
  • a stent delivery system 1 is schematically composed of a distal end shaft 11, a spirally-arranged protruding portion 21, an inner shaft 31, a stent 41, an outer shaft 51, and a connector 61.
  • the distal end shaft 11 has an inner cavity 11a, and a tapered portion 11b having an outer diameter gradually increasing from a distal end to a proximal end.
  • the inner cavity 11a can be composed of e.g. a through-hole passing from the distal end to the proximal end.
  • the tapered portion 11b it is possible to adopt a tapered portion that has e.g. an outer periphery shape gradually increasing in diameter from the distal end to the proximal end (see FIG. 1 ), a tapered portion having a diameter gradually increasing from the distal end to the proximal end (not illustrated), and a combination thereof (not illustrated), or the like.
  • a guide wire not illustrated is inserted into the inner cavity 11a, and the stent delivery system 1 advances and retreats along the guide wire.
  • a material constituting the distal end shaft 11 preferably has antithrombogenicity, flexibility, and biocompatibility because the shaft is inserted into a body cavity.
  • a resin material such as a polyamide resin, a polyolefin resin, a polyester resin, a polyurethane resin, a silicone resin, and a fluororesin; a metal material such as a stainless steel and a superelastic alloy (nickel-titanium alloy), and the like.
  • the distal end shaft 11 may have various coating films (not illustrated) on a side of an outer peripheral face 11c of the distal end shaft 11.
  • coating films include a protective film (typified by a plating film) for protecting the surface of the distal end shaft 11, a base film for improving adhesiveness between the distal end shaft 11 and a spirally-arranged protruding portion 21 described later, and the like.
  • the spirally-arranged protruding portion 21 is provided on the outer peripheral face 11c of the tapered portion 11b and has a gap 21a between adjacent sections along the long axis direction of the distal end shaft 11 (adjacent protruding portions 21 are separated in the long axis direction).
  • this spirally-arranged protruding portion 21 protrudes from the outer peripheral face 11c of the distal end shaft 11 outward in a radial direction of this distal end shaft 11, and is formed such that the outermost periphery of the spirally-arranged protruding portion 21 (see the two-dot chain line 21b in FIG.
  • the distal end shaft 11 is located on the radial outside of the outermost periphery of the distal end shaft (in this embodiment, the outer shape of the proximal end of the distal end shaft 11) in a frontal view from the distal end side in the long axis direction of the stent delivery system 1.
  • the spirally-arranged protruding portion 21 can be formed as a continuous or intermittent single-thread or multi-thread protruding portion.
  • the spirally-arranged protruding portion 21 can also be formed by spirally winding one or more wires around the outer peripheral face 11c of the distal end shaft 11.
  • the spirally-arranged protruding portion 21 may be either integrated with or separated from the distal end shaft 11.
  • the spirally-arranged protruding portion 21 is formed as a continuous single-thread protruding portion so as to be integrated with the distal end shaft 11 by casting or the like.
  • a part of the distal end shaft 11, where the spirally-arranged protruding portion 21 is formed may be any part between the distal end and the proximal end of the distal end shaft 11 in the long axis direction.
  • the spirally-arranged protruding portion 21 does not constitute a blade (shaped not to cut biological tissues). That means, the spirally-arranged protruding portion 21 preferably has a transverse section (section orthogonal to the spiral direction of the spirally-arranged protruding portion 21) in which an outside end portion (apex portion) of the distal end shaft 11 in the radial direction is not an acute corner portion. Examples of such an end portion include an end portion composed of an obtuse corner, an end portion composed of a corner portion shaped so as to include a curve (e.g. a curve including a part of a circle or an ellipse, etc.), and the like.
  • a curve e.g. a curve including a part of a circle or an ellipse, etc.
  • the stent delivery system 1 can widen a hole of an object without damaging biological tissues on an inner wall face of the hole of the object when performing a preliminary operation (preliminary widening of a constricted part or the like before inserting a diameter-decreased stent).
  • the same material as the material constituting the aforementioned distal end shaft, or the like can be adopted as a material constituting the spirally-arranged protruding portion 21.
  • the inner shaft 31 is connected to the proximal end of the distal end shaft 11, has an inner cavity 31a communicating with the inner cavity 11a of the distal end shaft 11, and extends toward the proximal end side of the distal end shaft 11 in the long axis direction.
  • the inner shaft 31 is composed of e.g. a through-hole through which the inner cavity 31a passes from the distal end to the proximal end.
  • the outer peripheral face of the inner shaft 31 has a hollow cylindrical face on at least a part in the long axis direction so as to hold the stent 41 (described later).
  • the outer peripheral face of the inner shaft 31 may have a lock portion 31b for locking the proximal end of the stent 41.
  • a proximal end-side part of the outer peripheral face of the inner shaft 31 can be formed in a shape suited to an inner peripheral face of an inner cavity 61a of the connector 61 (described later) so as to hold the connector 61 slidably.
  • a handle 71 for rotating the distal end shaft 11 via the inner shaft 31 is connected to the proximal end of the inner shaft 31.
  • the inner shaft 31 and the proximal end of the distal end shaft 11 can be connected to each other, and the proximal end of the inner shaft 31 and the handle 71 can be connected to each other, e.g. by jointing using welding, adhesion using an adhesive, or the like.
  • the same material as the material constituting the aforementioned distal end shaft 11, or the like can be adopted, because the shaft is inserted into the body cavity.
  • the stent 41 is a self-expanding member that covers the inner shaft 31 and is expandable and contractable in the radial direction of this inner shaft 31.
  • this stent 41 for example, a stent woven into a mesh shape using one or a plurality of metal wires 41a (see FIG. 1 ), a stent formed into a mesh shape by cutting a part of a substantially-hollow cylindrical body and boring holes thereon using laser processing or the like (not illustrated), and the like can be adopted.
  • the same material as the material constituting the aforementioned distal end shaft 11, or the like can be adopted, because the stent is placed in the body cavity.
  • the outer shaft 51 covers the inner shaft 31 and is slidable along the long axis direction of the inner shaft 31.
  • the outer shaft 51 can be composed of e.g. a hollow cylindrical member having a through-hole formed from the distal end to the proximal end such that the stent 41 is wrapped (supported) by an inner peripheral face 51a of the outer shaft 51 and the outer shaft 51 can slide along the long axis direction of the inner shaft 31.
  • the outer shaft 51 slides in the long axis direction of the inner shaft 31 between the first position where the stent 41 in a contracted state is covered and the second position on the proximal end side of the stent 41.
  • the first position refers to a position where the entire stent 41 in the contracted state (non-expanded state) is housed inside the outer shaft 51 (see FIG. 1 )
  • the second position refers to a position where the outer shaft 51 is located on the proximal end side of the first position and the stent 41 is completely exposed to the outside (see FIG. 3 ).
  • the outer shaft 51 can slide e.g. by connecting the proximal end of the outer shaft 51 to the connector 61 and moving the connector 61 forward and backward along the long axis direction.
  • An outermost periphery 51b (having the same distal outer shape as of the outer shaft 51, in this embodiment) of the outer shaft 51 is arranged to fit inside the outermost periphery (see the two-dot chain line 21b in FIG. 1 ) of the spirally-arranged protruding portion 21 in a frontal view from the distal end side in the long axis direction of the distal end shaft 11.
  • the outer diameter of the proximal end of the distal end shaft 11 and the outer diameter of the distal end of the outer shaft 51 substantially coincide with each other, and the proximal end of the distal end shaft 11 and the distal end of the outer shaft 51 abuts on each other such that an outer peripheral edge of the proximal end of the distal end shaft 11 and an outer peripheral edge of the distal end of the outer shaft 51 coincide with each other at the first position (see FIG. 1 ).
  • the outer shaft 51 can be advanced while the boundary portion B is not caught by an inner wall of the constricted part or the like, resulting in smooth placement of the stent 41.
  • the same material as the material constituting the aforementioned distal end shaft 11, or the like can be adopted, because the shaft is inserted into the body cavity.
  • the connector 61 is a part at which an operator operates the stent delivery system 1.
  • This connector 61 has e.g. the through-hole 61a along the long axis direction and can be configured such that the inner shaft 31 penetrates this through-hole 61a.
  • the outer shape of the connector 61 is not particularly limited as long as the effects of the disclosed embodiments are not impaired.
  • the connector 61 can be connected to e.g. the proximal end of the outer shaft 51 by jointing using welding, adhesion using an adhesive, or the like.
  • the distal end shaft 11 ordinarily has outer diameters of 0.8 to 3.0 mm on the distal end and 1.4 to 5.0 mm on the proximal end.
  • the spirally-arranged protruding portion 21 has a maximum diameter of 1.6 to 6.0 mm on the outermost periphery.
  • the outer shaft 51 has an outer diameter of 1.4 to 6.0 mm.
  • the stent 41 in a contracted state has an outer diameter of 0.7 to 2.0 mm and a length of 50 to 250 mm.
  • the inner cavities 11a and 31a of the distal end shaft 11 and the inner shaft 31 have an inner diameter of 0.5 to 1.5 mm.
  • a guide wire W is inserted into the constricted part C prior to insertion of the stent delivery system 1. (see FIG. 4A ).
  • the proximal end of the guide wire W is inserted into the inner cavity 11a of the stent delivery system 1 so as to protrude from the proximal end of the stent delivery system 1, and then this stent delivery system 1 is pushed forward to the immediate vicinity of the constricted part C along the guide wire W.
  • the distal end shaft 11 is inserted into the constricted part C from the distal end, then handle 71 is rotated to advance the stent delivery system 1 while the spirally-arranged protruding portion 21 is screwed into an inner wall Cw of the constricted part C (see FIG. 4B ), and the advancement of the stent delivery system 1 is stopped at a position where the stent 41 enters the constricted part C (see FIG. 4C ).
  • the preliminary widening of the constricted part C is completed.
  • the stent 41 possessed by the stent delivery system 1 is separated from the stent delivery system 1 to widen the preliminarily widened constricted part C.
  • the outer shaft 51 is moved (slid) from the first position to the second position by pulling the connector 61 toward the proximal end side with respect to the inner shaft 31.
  • the stent 41 is gradually exposed as the outer shaft 51 is moved from the first position to the second position.
  • the gradually exposed part of the stent 41 expands outward in the radial direction owing to the self-expanding action of the stent 41 (see FIG. 4D ).
  • the stent 41 In a state that the stent 41 is fully exposed to the outside in the second position, the stent 41 increases in diameter as a whole to widen the inner wall Cw of the constricted part C outward in the radial direction (see FIG. 4E ). Subsequently, the distal end shaft 11 is drawn out toward the proximal end side so as to pass through the inside of the self-expanded stent 41 (see FIG. 4F ), and the stent delivery system 1 from which the stent 41 is separated is removed out of the body. Thereby, the series of procedures for placing the stent 41 in the digestive tract K is completed.
  • the stent delivery system 1 has the aforementioned configuration, widening of the constricted part C and placement of the stent 41 can be continuously performed, and the stent 41 can be smoothly placed in a body cavity such as the digestive tract K.
  • the stent delivery system 1 in which the outer peripheral edge of the proximal end of the distal end shaft 11 and the outer peripheral edge of the distal end of the outer shaft 51 coincide with each other at the first position, has been explained, but the stent delivery system 1 may have any aspect as long as the outermost periphery of the outer shaft 51 fits inside the outermost periphery of the spirally-arranged protruding portion 21 in a frontal view.
  • a stent delivery system examples include a stent delivery system 1m1 in which an outermost periphery of an outer shaft 51m1 has the same shape as of the outermost periphery of the spirally-arranged protruding portion 21 in a frontal view (see FIG. 5A ), a stent delivery system 1m2 in which an outermost periphery of an outer shaft 51m2 is located inside the outermost periphery of the spirally-arranged protruding portion 21 and outside the outer peripheral edge of the proximal end of the distal end shaft 11 (see FIG.
  • a stent delivery system 1m3 in which an outermost periphery of an outer shaft 51m3 is located inside the outermost periphery of the spirally-arranged protruding portion 21 and inside the outer peripheral edge of the proximal end of the distal end shaft 11 (see FIG. 5C ), and the like.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
EP20766590.2A 2019-03-05 2020-01-30 Système de pose d'endoprothèse Withdrawn EP3936089A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2019039575A JP7216578B2 (ja) 2019-03-05 2019-03-05 ステントデリバリーシステム
PCT/JP2020/003348 WO2020179293A1 (fr) 2019-03-05 2020-01-30 Système de pose d'endoprothèse

Publications (2)

Publication Number Publication Date
EP3936089A1 true EP3936089A1 (fr) 2022-01-12
EP3936089A4 EP3936089A4 (fr) 2022-11-16

Family

ID=72337195

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20766590.2A Withdrawn EP3936089A4 (fr) 2019-03-05 2020-01-30 Système de pose d'endoprothèse

Country Status (5)

Country Link
US (1) US20210393425A1 (fr)
EP (1) EP3936089A4 (fr)
JP (1) JP7216578B2 (fr)
CN (1) CN113423365A (fr)
WO (1) WO2020179293A1 (fr)

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6322586B1 (en) * 2000-01-10 2001-11-27 Scimed Life Systems, Inc. Catheter tip designs and method of manufacture
US20050288766A1 (en) 2004-06-28 2005-12-29 Xtent, Inc. Devices and methods for controlling expandable prostheses during deployment
JP2008011867A (ja) 2006-05-25 2008-01-24 Nippon Zeon Co Ltd ダイレーター、ダイレーターの製造方法、およびシースイントロデューサー
CN103142336B (zh) 2013-03-29 2014-12-10 孙思予 一种一体式支架置入器
US10350067B2 (en) * 2015-10-26 2019-07-16 Edwards Lifesciences Corporation Implant delivery capsule
US10357351B2 (en) * 2015-12-04 2019-07-23 Edwards Lifesciences Corporation Storage assembly for prosthetic valve
WO2018125806A1 (fr) 2016-12-29 2018-07-05 Boston Scientific Scimed, Inc. Système de distribution d'hydratation pour endoprothèses vasculaires

Also Published As

Publication number Publication date
JP2020141799A (ja) 2020-09-10
JP7216578B2 (ja) 2023-02-01
WO2020179293A1 (fr) 2020-09-10
EP3936089A4 (fr) 2022-11-16
CN113423365A (zh) 2021-09-21
US20210393425A1 (en) 2021-12-23

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